A Phase III Study of Penpulimab or Placebo Plus Chemotherapy in People with Recurrent or Metastatic Nasopharyngeal Carcinoma


Full Title

A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined with Chemotherapy versus Placebo Combined with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma


The purpose of this study is to see if adding the immunotherapy drug penpulimab to standard chemotherapy improves treatment effectiveness in people with recurrent or metastatic cancer of the nasopharynx. Penpulimab works by taking the brakes off the immune response, boosting the power of immune cells to detect and destroy cancer cells.

Participants in this study will be randomly assigned to receive cisplatin and gemcitabine chemotherapy with either penpulimab or a placebo (inactive drug). Patients in the placebo group who experience cancer growth may then have the option of receiving penpulimab. The medications are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have recurrent or metastatic nasopharyngeal cancer.
  • Patients may not have previously received treatment for advanced disease.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18-75.


For more information about this study and to inquire about eligibility, please contact the office of Dr. David Pfister at 646-888-4237.




Phase III (phase 3)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID